FDA accepts to review Pfizer’s NDA for rheumatoid arthritis drug Xeljanz

For the NDA, the FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in February 2016.

The NDA of Xeljanz 11mg is based on data from a clinical pharmacology program designed to show equivalence in key pharmacokinetic parameters to Xeljanz 5mg twice daily.

Pfizer Global Medical Affairs head and senior vice-president Rory O’Connor said: "This filing underscores our commitment to helping advance patient care and our goal of providing innovative solutions for patients with RA.

"If approved, it would bring us one step closer to offering the first and only once-daily oral Janus kinase inhibitor treatment for those living with moderate to severe RA who have had an inadequate response or intolerance to methotrexate."

The drug has been approved in 40 countries around the world for the treatment of moderate to severe rheumatoid arthritis (RA) and in the US, Xeljanz has a boxed warning for serious infections and malignancies.

The company is committed to building on the science and understanding of Janus kinase (JAK) inhibition and Xeljanz through a clinical development program in a range of immune-mediated inflammatory conditions in the areas of rheumatology, dermatology and gastroenterology.

Currently, a supplemental new drug application (sNDA)for Xeljanz 10mg and 5mg tablets twice daily is under review with the FDA to treat adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.